Effects of Microcrystalline Titanium Dioxide With Covalently Linked Monovalent Silver Ions on Complications After Total Hysterectomy ( ISTIAB-0)

NCT03791294 | Unknown Phase 3 DMC

• 1 other identifier: ISTIAB-0
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total hysterectomy is one of the most performed surgical procedures in the world and it is associated with post-operative complications. The postoperative morbidity rate is estimated to vary from 3% to 8% with a readmission rate of 5-7%. The most frequent postoperative complications are urinary tract infections, wound infection of the vaginal vault, vault cellulitis, bleeding, suture dehiscence, pelvic abscess. The introduction of routine antibiotic prophylaxis has significantly reduced the risk of infectious complications, which however remains higher than other "clean" surgery, mainly due to contamination by the vaginal bacterial flora. In this scenario, the introduction of adjuvant factors acting on bacterial flora, can contribute to reduce the risk of post-surgical complications. The cationic silver ions (Ag +) stabilized by covalent link with Titanium dioxide (TiO2), the TIAB, maximizes the properties of silver by optimizing the antibiotic action and disruptive properties of the pathogenic biofilm of bacteria and fungi. Thanks to these properties, TIAB is able to enhance the antibiotic action by reducing the risk of antibiotic resistance and recurrent infections linked to the biofilm. Re-establishing the optimal vaginal microenvironment represents a fundamental step reducing the risk of infections in the surgical site, since the vagina is a non-sterile environment populated by bacterial species that can generate biofilm and potentially infect the site of surgery. In addition to microbicidal and disruptive biofilm activity, TIAB has demonstrated a direct action on tissue regeneration processes by stimulating the production of collagen and its modeling. Different clinical trials have reported a cicatrizing and re-epithelializing action of TIAB administered vaginally in the context of cervical conization for pathology related to HPV. Without showing any notable adverse effects or a negative action on lactobacillary flora with an overall good therapy tolerance by patients. On the basis of the available evidence, the investigators conduct a randomized controlled clinical trial to determine if TIAB treatment in the formulation of vaginal capsules TIAGIN (TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract) is able to reduce the incidence of infectious complications, that are related to altered healing of post-hysterectomy vaginal suture.

Conditions

Infection; Bleeding; Complication, Postoperative

Outcome Measures

Primary Outcomes (5)

• Vaginal bleeding

  at least one episode of red vaginal blood loss

  At the 30th post operative day

• Vaginal vault infection

  at least one episode of inflammation and infection in the vaginal vault suture requiring antibiotic therapy

  At the 30th post operative day

• Urinary tract infection

  at least one episode of signs and symptoms requiring empiric antibiotic therapy

  At the 30th post operative day

• Dehiscence of vaginal vault suture

  Dehiscence of vaginal vault suture requiring repeat surgery

  At the 30th post operative day

• Readmission

  At least one episode of readmission related to postoperative complications

  At the 30th post operative day

Secondary Outcomes (1)

• Adverse events

  At the 30th post operative day

Study Arms (2)

TIAB treatment

EXPERIMENTAL

From the first postoperative day for ten days, single vaginal capsule per day of TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, and Aloe Barbadensis Extract vaginal capsule.

Drug: TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions

Control

NO INTERVENTION

No treatment

Interventions

TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions DRUG

TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract

Also known as: TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract

TIAB treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women underwent laparoscopic total hysterectomy for benign gynecological pathology

You may not qualify if:

• Women underwent non-laparoscopic total hysterectomy
• Women underwent laparoscopic total hysterectomy for malignant pathology
• Patients with diabetes mellitus in insulin therapy
• Smoking patients
• Patients suffering from chronic rheumatic diseases or chronic diseases not in adequate control.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Conditions

Infections; Hemorrhage; Postoperative Complications

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Simone Garzon, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Fabio Ghezzi, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Jvan Casarin, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Garzon, M.D.

CONTACT

+39 347 0782287; sgarzon@studenti.uninsubria.it

Antonio Simone Laganà, M.D.

CONTACT

+39 329 6279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 2, 2019
• Study Start: January 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 2, 2019

Record last verified: 2018-12